Now, Alprolix (rFIXFc) has been approved by the European Commission (EC). It will be available in all 28 countries of the EU, where it’s the only treatment of its kind for hemophilia B.

The therapy is a recombinant protein that replaces a clotting factor (IX)- which is not naturally expressed in patients. The protein has also been fused to a portion of a common antibody, IgG1.

This modification enables Alprolix to prolong the time the therapy remains in the body – providing longer protection to patients, with fewer injections.

Mechanism of prolonged action of Alprolix (Source: Alprolix.com)

Sobi developed and commercializes Alprolix in collaboration withBiogen(from the US, but expanding in Switzerland). Biogen leads development and manufacturing for Alprolix, while Sobi has rights to final development.

Alprolix had already been approved in the US, Canada and other countries, and is the first advance in hemophilia management in almost 20 years.

Europe is a major market of Sobi’s commercialization territories for Alprolix, so EU approval is a big win for this Swedish Biopharma.

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